Description

Venetoclax D8 is a deuterated isotopologue of the selective BCL-2 inhibitor Venetoclax, specifically labeled with eight deuterium atoms. This stable isotope-labeled compound is a critical reference standard and internal standard for the precise quantification and pharmacokinetic studies of Venetoclax in biological matrices using advanced analytical techniques like LC-MS/MS. It is essential for pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in drug metabolism, bioanalytical method development, and ensuring regulatory compliance for this important oncology therapeutic.

Application

• Bioanalytical Reference Standard: Serves as a primary standard for calibrating mass spectrometry instruments in quantitative bioanalysis of Venetoclax.
• Pharmacokinetic (PK) and Metabolism Studies: Used as an internal standard to ensure accuracy and precision in measuring drug concentration levels in plasma, serum, and tissues.
• Drug Development and Research: Facilitates ADME (Absorption, Distribution, Metabolism, Excretion) studies during the preclinical and clinical development phases of Venetoclax and related compounds.
• Clinical Trial Support: Critical for generating reliable and GLP-compliant data in clinical trials involving Venetoclax therapy.
• Impurity Profiling and Characterization: Aids in the identification and quantification of metabolites or related substances in drug substance and product analysis.
• Regulatory Submission: Provides essential data traceable to certified standards for submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Venetoclax D8
CAS No.	1257051-06-1
Molecular Formula	C45H42D8ClN7O7S
Molecular Weight	872.46 g/mol (approximate)
Synonyms	ABT-199 D8; ABT199 D8; GDC-0199 D8; Venclexta D8; Venclyxto D8; 4-[4-[[2-(4-Chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-N-[[3-nitro-4-[[(tetrahydro-2H-pyran-4-yl)methyl]amino]phenyl]sulfonyl]-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide-d8; BCL-2 Inhibitor D8
EINECS	Contact for details

Quality Control

Our Venetoclax D8 is manufactured under strict quality control protocols to ensure the highest isotopic purity and chemical integrity. Each batch is characterized using advanced analytical techniques including NMR, HPLC, and mass spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing isotopic enrichment (typically ≥98% D), chemical purity (typically ≥95% by HPLC), and confirming identity and structure. We support cGMP and ISO 9001 compliant processes for research and regulatory applications.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. This product is hygroscopic (moisture-sensitive). Allow the vial to warm to room temperature in a desiccator before opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Isotopic Purity (D8)	≥ 98.0 atom % D
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Meets ICH guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.